Table 3.
Plasma PK of febuxostat in the presence of verinurad vs febuxostat alone (geometric mean (95% CIs)) (PK population)
| Febuxostat (mg) |
Verinurad (mg) |
Patient, n | Geometric mean (95% CI) | GMR (%) (90% CI) | ||
| Cmax (µg/mL) | AUC0-24 (µg·h/mL) | Cmax | AUC0-24 | |||
| 40 | 0 | 59 | 0.698 (0.625 to 0.780) | 3.10 (2.83 to 3.40) | – | – |
| 2.5 | 12 | 0.626 (0.481 to 0.816) | 2.76 (2.15 to 3.54) | 91.2 (69.3 to 120) | 94.2 (88.1 to 101) | |
| 5 | 12 | 0.517 (0.390 to 0.685) | 2.50 (2.02 to 3.09) | 85.6 (75.7 to 96.7) | 92.4 (89.0 to 95.8) | |
| 10 | 24 | 0.628 (0.500 to 0.788) | 3.07 (2.65 to 3.56) | 88.9 (70.4 to 112)* | 95.4 (89.4 to 102)* | |
| 15 | 23 | 0.695 (0.552 to 0.874) | 2.77 (2.42 to 3.18) | 116 (89.0 to 152)† | 88.3 (82.4 to 94.7)† | |
| 20 | 11 | 0.688 (0.502 to 0.942) | 2.52 (1.98 to 3.21) | 114 (92.0 to 141) | 94.1 (89.4 to 99.0) | |
| 80 | 0 | 50 | 1.47 (1.30 to 1.66) | 6.85 (6.24 to 7.52) | – | – |
| 2.5 | 12 | 1.95 (1.46 to 2.62) | 6.36 (5.01 to 8.09) | 146 (130 to 165) | 98.6 (94.5 to 103) | |
| 5 | 12 | 1.08 (0.77 to 1.53) | 5.19 (4.27 to 6.31) | 89.9 (68.8 to 117) | 89.3 (82.8 to 96.3) | |
| 10 | 13 | 1.74 (1.58 to 1.91) | 7.70 (6.64 to 8.94) | 101 (87.9 to 116) | 94.2 (90.7 to 97.9) | |
| 15 | 11 | 2.07 (1.60 to 2.68) | 6.60 (5.68 to 7.66) | 123 (88.3 to 173) | 92.9 (84.1 to 103) | |
AUC0-24, area under the concentration–time curve from time 0 up to 24 hours postdose; Cmax, maximum observed plasma concentration; GMR, geometric mean ratio; t1/2, plasma terminal half-life; Tmax, time of maximum observed plasma concentration.
*Cohort 1 (n=12).
†Cohort 2 (n=12).